Asian drug-makers ready to make generic versions of Tamiflu

Posted AtTodayOnline.com

Drug-makers across Asia are jostling to make generic
versions of Tamiflu once patent holder Roche relaxes
its grip on the anti-viral pill that could save many
lives in case of a bird flu pandemic.
.
From India to Southeast Asia, talks are underway with
the Swiss pharmaceutical giant for sub-licenses and
other arrangements to manufacture the highly sought-after
drug as governments beef up their stockpiles.
.
Roche, which had kept a tight rein on the manufacturing
process to ensure quality control, succumbed to global
pressure and agreed this month to share the technology
amid escalating warnings of a pandemic that could kill
millions.
.
Tamiflu is not a vaccine against avian flu, but eases
its impact and thus boosts patients' chances to survive
infection.
.
Evidence that bird flu has spread to Europe from Asia,
where the lethal H5N1 strain has killed more than 60
people since 2003, has increased demand for the drug
amid fears the virus will become easily transferable
among humans.
.
"Considering the recent spread of H5N1 virus, the Roche
decision was the responsible thing to do and should
be applauded," said Duane Gubler, director of the Hawaii-based
Asia-Pacific Institute for Tropical Medicine and Infectious
Diseases.
.
"If there is a pandemic, that decision could result
in helping to save many lives," he told AFP.
.
Koh Choon Hui, managing director of Roche Singapore
Pte Ltd, said the Basel-based group has been approached
by "around 100 companies including some governments"
in Asia for the production of Tamiflu.
.
"These requests are currently being assessed. It is
too early to comment who these governments and companies
are," Koh told AFP.
.
Roche is "willing to collaborate with companies which
have expertise in certain specialist manufacturing steps
such as fermentation and azide chemistry," he said.
.
It is also "willing to grant sub-licenses ... to companies
who can realistically produce substantial amounts of
Tamiflu for emergency pandemic use in accordance with
appropriate quality specifications, safety and regulatory
requirements."
.
Roche has said that the production of Tamiflu involves
a complex, 10-step process which takes about 12 months
and must be carried out in specialised factories.
.
Among the Asian firms interested in manufacturing the
medication are India's biggest generic drug-makers Ranbaxy
Laboratories Ltd. and Cipla, the first company to make
cheap AIDS drugs.
.
"We have initiated the process of dialogue with Roche
for a non-exclusive global voluntary license for the
manufacture and sale of the generic version of Tamiflu,"
Ranbaxy spokesman Ramesh L. Adige told AFP.
.
He said Ranbaxy could manufacture the active pharmaceutical
ingredients for Tamiflu "in a couple of months" after
meeting issues relating to intellectual property and
other regulatory clearances.
.
Cipla said earlier this month said it would follow its
strategy with the anti-AIDS drug by developing a low-cost
version of Tamiflu.
.
"We have no deal with Roche on the product, but could
explore a tie-up," Cipla joint managing director Amar
Lula told AFP in New Delhi.
.
In Taiwan, a health department official, Li Jih-heng.
said authorities are planning a trial production of
Tamiflu in December.
.
"We will continue efforts seeking a patent authorisation
from the Swiss company Roche to mass manufacture Tamiflu
but the trial production will go ahead to meet emergency
needs," Li told AFP in Taipei.
.
"The drug will be used to contain bird flu in the event
of an outbreak, not for commercial purposes."
.
Taiwanese legislators, citing threats of a possible
outbreak, have urged health authorities to immediately
mass-produce the drug even without Roche's authorisation.
.
Roche's Shanghai office has said it was also in touch
with the mainland Chinese government and had provided
it with full and updated information about the drug.
.
Roche is willing to allow other companies in China or
the government to produce the drug, it said.
.
Vietnam, which accounts for two-thirds of the H5N1 strain's
human fatalities, is in contact with Roche, according
to Cao Minh Quang, director of the Pharmaceuticals Administration
Department in Hanoi.
.
Quang said Vietnam could even decide to produce the
anti-viral drug without a licence in case of a pandemic
-- a situation in which governments would be under intense
pressure to put public health above respecting copyright
laws.
.
Koh, the managing director of Roche's Singapore office,
said he hoped the situation would not reach such a point.
.
"As Roche is willing to discuss and collaborate on technical
matters for the manufacturing of Tamiflu, there is no
need for these countries to violate patent laws," he
said.
.
Singapore said it was increasing its stockpiles of Tamiflu
but was not in talks with Roche to manufacture the drug.
.
Currently, Singapore has Tamiflu supplies to treat 430,000
people and expects more deliveries to enable it to treat
1.05 million people, or a quarter of the population,
within a year, the Ministry of Health (MOH) said.
.
"However, MOH will continue to watch the developments
in the area of generic anti-viral drugs and keep our
options open," it said. â AFP
Drug-makers across Asia are jostling to make generic
versions of Tamiflu once patent holder Roche relaxes
its grip on the anti-viral pill that could save many
lives in case of a bird flu pandemic.
.
From India to Southeast Asia, talks are underway with
the Swiss pharmaceutical giant for sub-licenses and
other arrangements to manufacture the highly sought-after
drug as governments beef up their stockpiles.
.
Roche, which had kept a tight rein on the manufacturing
process to ensure quality control, succumbed to global
pressure and agreed this month to share the technology
amid escalating warnings of a pandemic that could kill
millions.
.
Tamiflu is not a vaccine against avian flu, but eases
its impact and thus boosts patients' chances to survive
infection.
.
Evidence that bird flu has spread to Europe from Asia,
where the lethal H5N1 strain has killed more than 60
people since 2003, has increased demand for the drug
amid fears the virus will become easily transferable
among humans.
.
"Considering the recent spread of H5N1 virus, the Roche
decision was the responsible thing to do and should
be applauded," said Duane Gubler, director of the Hawaii-based
Asia-Pacific Institute for Tropical Medicine and Infectious
Diseases.
.
"If there is a pandemic, that decision could result
in helping to save many lives," he told AFP.
.
Koh Choon Hui, managing director of Roche Singapore
Pte Ltd, said the Basel-based group has been approached
by "around 100 companies including some governments"
in Asia for the production of Tamiflu.
.
"These requests are currently being assessed. It is
too early to comment who these governments and companies
are," Koh told AFP.
.
Roche is "willing to collaborate with companies which
have expertise in certain specialist manufacturing steps
such as fermentation and azide chemistry," he said.
.
It is also "willing to grant sub-licenses ... to companies
who can realistically produce substantial amounts of
Tamiflu for emergency pandemic use in accordance with
appropriate quality specifications, safety and regulatory
requirements."
.
Roche has said that the production of Tamiflu involves
a complex, 10-step process which takes about 12 months
and must be carried out in specialised factories.
.
Among the Asian firms interested in manufacturing the
medication are India's biggest generic drug-makers Ranbaxy
Laboratories Ltd. and Cipla, the first company to make
cheap AIDS drugs.
.
"We have initiated the process of dialogue with Roche
for a non-exclusive global voluntary license for the
manufacture and sale of the generic version of Tamiflu,"
Ranbaxy spokesman Ramesh L. Adige told AFP.
.
He said Ranbaxy could manufacture the active pharmaceutical
ingredients for Tamiflu "in a couple of months" after
meeting issues relating to intellectual property and
other regulatory clearances.
.
Cipla said earlier this month said it would follow its
strategy with the anti-AIDS drug by developing a low-cost
version of Tamiflu.
.
"We have no deal with Roche on the product, but could
explore a tie-up," Cipla joint managing director Amar
Lula told AFP in New Delhi.
.
In Taiwan, a health department official, Li Jih-heng.
said authorities are planning a trial production of
Tamiflu in December.
.
"We will continue efforts seeking a patent authorisation
from the Swiss company Roche to mass manufacture Tamiflu
but the trial production will go ahead to meet emergency
needs," Li told AFP in Taipei.
.
"The drug will be used to contain bird flu in the event
of an outbreak, not for commercial purposes."
.
Taiwanese legislators, citing threats of a possible
outbreak, have urged health authorities to immediately
mass-produce the drug even without Roche's authorisation.
.
Roche's Shanghai office has said it was also in touch
with the mainland Chinese government and had provided
it with full and updated information about the drug.
.
Roche is willing to allow other companies in China or
the government to produce the drug, it said.
.
Vietnam, which accounts for two-thirds of the H5N1 strain's
human fatalities, is in contact with Roche, according
to Cao Minh Quang, director of the Pharmaceuticals Administration
Department in Hanoi.
.
Quang said Vietnam could even decide to produce the
anti-viral drug without a licence in case of a pandemic
-- a situation in which governments would be under intense
pressure to put public health above respecting copyright
laws.
.
Koh, the managing director of Roche's Singapore office,
said he hoped the situation would not reach such a point.
.
"As Roche is willing to discuss and collaborate on technical
matters for the manufacturing of Tamiflu, there is no
need for these countries to violate patent laws," he
said.
.
Singapore said it was increasing its stockpiles of Tamiflu
but was not in talks with Roche to manufacture the drug.
.
Currently, Singapore has Tamiflu supplies to treat 430,000
people and expects more deliveries to enable it to treat
1.05 million people, or a quarter of the population,
within a year, the Ministry of Health (MOH) said.
.
"However, MOH will continue to watch the developments
in the area of generic anti-viral drugs and keep our
options open," it said. â AFP
Drug-makers across Asia are jostling to make generic
versions of Tamiflu once patent holder Roche relaxes
its grip on the anti-viral pill that could save many
lives in case of a bird flu pandemic.
.
From India to Southeast Asia, talks are underway with
the Swiss pharmaceutical giant for sub-licenses and
other arrangements to manufacture the highly sought-after
drug as governments beef up their stockpiles.
.
Roche, which had kept a tight rein on the manufacturing
process to ensure quality control, succumbed to global
pressure and agreed this month to share the technology
amid escalating warnings of a pandemic that could kill
millions.
.
Tamiflu is not a vaccine against avian flu, but eases
its impact and thus boosts patients' chances to survive
infection.
.
Evidence that bird flu has spread to Europe from Asia,
where the lethal H5N1 strain has killed more than 60
people since 2003, has increased demand for the drug
amid fears the virus will become easily transferable
among humans.
.
"Considering the recent spread of H5N1 virus, the Roche
decision was the responsible thing to do and should
be applauded," said Duane Gubler, director of the Hawaii-based
Asia-Pacific Institute for Tropical Medicine and Infectious
Diseases.
.
"If there is a pandemic, that decision could result
in helping to save many lives," he told AFP.
.
Koh Choon Hui, managing director of Roche Singapore
Pte Ltd, said the Basel-based group has been approached
by "around 100 companies including some governments"
in Asia for the production of Tamiflu.
.
"These requests are currently being assessed. It is
too early to comment who these governments and companies
are," Koh told AFP.
.
Roche is "willing to collaborate with companies which
have expertise in certain specialist manufacturing steps
such as fermentation and azide chemistry," he said.
.
It is also "willing to grant sub-licenses ... to companies
who can realistically produce substantial amounts of
Tamiflu for emergency pandemic use in accordance with
appropriate quality specifications, safety and regulatory
requirements."
.
Roche has said that the production of Tamiflu involves
a complex, 10-step process which takes about 12 months
and must be carried out in specialised factories.
.
Among the Asian firms interested in manufacturing the
medication are India's biggest generic drug-makers Ranbaxy
Laboratories Ltd. and Cipla, the first company to make
cheap AIDS drugs.
.
"We have initiated the process of dialogue with Roche
for a non-exclusive global voluntary license for the
manufacture and sale of the generic version of Tamiflu,"
Ranbaxy spokesman Ramesh L. Adige told AFP.
.
He said Ranbaxy could manufacture the active pharmaceutical
ingredients for Tamiflu "in a couple of months" after
meeting issues relating to intellectual property and
other regulatory clearances.
.
Cipla said earlier this month said it would follow its
strategy with the anti-AIDS drug by developing a low-cost
version of Tamiflu.
.
"We have no deal with Roche on the product, but could
explore a tie-up," Cipla joint managing director Amar
Lula told AFP in New Delhi.
.
In Taiwan, a health department official, Li Jih-heng.
said authorities are planning a trial production of
Tamiflu in December.
.
"We will continue efforts seeking a patent authorisation
from the Swiss company Roche to mass manufacture Tamiflu
but the trial production will go ahead to meet emergency
needs," Li told AFP in Taipei.
.
"The drug will be used to contain bird flu in the event
of an outbreak, not for commercial purposes."
.
Taiwanese legislators, citing threats of a possible
outbreak, have urged health authorities to immediately
mass-produce the drug even without Roche's authorisation.
.
Roche's Shanghai office has said it was also in touch
with the mainland Chinese government and had provided
it with full and updated information about the drug.
.
Roche is willing to allow other companies in China or
the government to produce the drug, it said.
.
Vietnam, which accounts for two-thirds of the H5N1 strain's
human fatalities, is in contact with Roche, according
to Cao Minh Quang, director of the Pharmaceuticals Administration
Department in Hanoi.
.
Quang said Vietnam could even decide to produce the
anti-viral drug without a licence in case of a pandemic
-- a situation in which governments would be under intense
pressure to put public health above respecting copyright
laws.
.
Koh, the managing director of Roche's Singapore office,
said he hoped the situation would not reach such a point.
.
"As Roche is willing to discuss and collaborate on technical
matters for the manufacturing of Tamiflu, there is no
need for these countries to violate patent laws," he
said.
.
Singapore said it was increasing its stockpiles of Tamiflu
but was not in talks with Roche to manufacture the drug.
.
Currently, Singapore has Tamiflu supplies to treat 430,000
people and expects more deliveries to enable it to treat
1.05 million people, or a quarter of the population,
within a year, the Ministry of Health (MOH) said.
.
"However, MOH will continue to watch the developments
in the area of generic anti-viral drugs and keep our
options open," it said. â AFP
Drug-makers across Asia are jostling to make generic
versions of Tamiflu once patent holder Roche relaxes
its grip on the anti-viral pill that could save many
lives in case of a bird flu pandemic.
.
From India to Southeast Asia, talks are underway with
the Swiss pharmaceutical giant for sub-licenses and
other arrangements to manufacture the highly sought-after
drug as governments beef up their stockpiles.
.
Roche, which had kept a tight rein on the manufacturing
process to ensure quality control, succumbed to global
pressure and agreed this month to share the technology
amid escalating warnings of a pandemic that could kill
millions.
.
Tamiflu is not a vaccine against avian flu, but eases
its impact and thus boosts patients' chances to survive
infection.
.
Evidence that bird flu has spread to Europe from Asia,
where the lethal H5N1 strain has killed more than 60
people since 2003, has increased demand for the drug
amid fears the virus will become easily transferable
among humans.
.
"Considering the recent spread of H5N1 virus, the Roche
decision was the responsible thing to do and should
be applauded," said Duane Gubler, director of the Hawaii-based
Asia-Pacific Institute for Tropical Medicine and Infectious
Diseases.
.
"If there is a pandemic, that decision could result
in helping to save many lives," he told AFP.
.
Koh Choon Hui, managing director of Roche Singapore
Pte Ltd, said the Basel-based group has been approached
by "around 100 companies including some governments"
in Asia for the production of Tamiflu.
.
"These requests are currently being assessed. It is
too early to comment who these governments and companies
are," Koh told AFP.
.
Roche is "willing to collaborate with companies which
have expertise in certain specialist manufacturing steps
such as fermentation and azide chemistry," he said.
.
It is also "willing to grant sub-licenses ... to companies
who can realistically produce substantial amounts of
Tamiflu for emergency pandemic use in accordance with
appropriate quality specifications, safety and regulatory
requirements."
.
Roche has said that the production of Tamiflu involves
a complex, 10-step process which takes about 12 months
and must be carried out in specialised factories.
.
Among the Asian firms interested in manufacturing the
medication are India's biggest generic drug-makers Ranbaxy
Laboratories Ltd. and Cipla, the first company to make
cheap AIDS drugs.
.
"We have initiated the process of dialogue with Roche
for a non-exclusive global voluntary license for the
manufacture and sale of the generic version of Tamiflu,"
Ranbaxy spokesman Ramesh L. Adige told AFP.
.
He said Ranbaxy could manufacture the active pharmaceutical
ingredients for Tamiflu "in a couple of months" after
meeting issues relating to intellectual property and
other regulatory clearances.
.
Cipla said earlier this month said it would follow its
strategy with the anti-AIDS drug by developing a low-cost
version of Tamiflu.
.
"We have no deal with Roche on the product, but could
explore a tie-up," Cipla joint managing director Amar
Lula told AFP in New Delhi.
.
In Taiwan, a health department official, Li Jih-heng.
said authorities are planning a trial production of
Tamiflu in December.
.
"We will continue efforts seeking a patent authorisation
from the Swiss company Roche to mass manufacture Tamiflu
but the trial production will go ahead to meet emergency
needs," Li told AFP in Taipei.
.
"The drug will be used to contain bird flu in the event
of an outbreak, not for commercial purposes."
.
Taiwanese legislators, citing threats of a possible
outbreak, have urged health authorities to immediately
mass-produce the drug even without Roche's authorisation.
.
Roche's Shanghai office has said it was also in touch
with the mainland Chinese government and had provided
it with full and updated information about the drug.
.
Roche is willing to allow other companies in China or
the government to produce the drug, it said.
.
Vietnam, which accounts for two-thirds of the H5N1 strain's
human fatalities, is in contact with Roche, according
to Cao Minh Quang, director of the Pharmaceuticals Administration
Department in Hanoi.
.
Quang said Vietnam could even decide to produce the
anti-viral drug without a licence in case of a pandemic
-- a situation in which governments would be under intense
pressure to put public health above respecting copyright
laws.
.
Koh, the managing director of Roche's Singapore office,
said he hoped the situation would not reach such a point.
.
"As Roche is willing to discuss and collaborate on technical
matters for the manufacturing of Tamiflu, there is no
need for these countries to violate patent laws," he
said.
.
Singapore said it was increasing its stockpiles of Tamiflu
but was not in talks with Roche to manufacture the drug.
.
Currently, Singapore has Tamiflu supplies to treat 430,000
people and expects more deliveries to enable it to treat
1.05 million people, or a quarter of the population,
within a year, the Ministry of Health (MOH) said.
.
"However, MOH will continue to watch the developments
in the area of generic anti-viral drugs and keep our
options open," it said. â AFP

Drug-makers across Asia are jostling to make generic
versions of Tamiflu once patent holder Roche relaxes
its grip on the anti-viral pill that could save many
lives in case of a bird flu pandemic.
.
From India to Southeast Asia, talks are underway with
the Swiss pharmaceutical giant for sub-licenses and
other arrangements to manufacture the highly sought-after
drug as governments beef up their stockpiles.
.
Roche, which had kept a tight rein on the manufacturing
process to ensure quality control, succumbed to global
pressure and agreed this month to share the technology
amid escalating warnings of a pandemic that could kill
millions.
.
Tamiflu is not a vaccine against avian flu, but eases
its impact and thus boosts patients' chances to survive
infection.
.
Evidence that bird flu has spread to Europe from Asia,
where the lethal H5N1 strain has killed more than 60
people since 2003, has increased demand for the drug
amid fears the virus will become easily transferable
among humans.
.
"Considering the recent spread of H5N1 virus, the Roche
decision was the responsible thing to do and should
be applauded," said Duane Gubler, director of the Hawaii-based
Asia-Pacific Institute for Tropical Medicine and Infectious
Diseases.
.
"If there is a pandemic, that decision could result
in helping to save many lives," he told AFP.
.
Koh Choon Hui, managing director of Roche Singapore
Pte Ltd, said the Basel-based group has been approached
by "around 100 companies including some governments"
in Asia for the production of Tamiflu.
.
"These requests are currently being assessed. It is
too early to comment who these governments and companies
are," Koh told AFP.
.
Roche is "willing to collaborate with companies which
have expertise in certain specialist manufacturing stepssuch
as fermentation and azide chemistry," he said.
.
It is also "willing to grant sub-licenses ... to companies
who can realistically produce substantial amounts of
Tamiflu for emergency pandemic use in accordance with
appropriate quality specifications, safety and regulatory
requirements."
.
Roche has said that the production of Tamiflu involves
a complex, 10-step process which takes about 12 months
and must be carried out in specialised factories.
.
Among the Asian firms interested in manufacturing the
medication are India's biggest generic drug-makers Ranbaxy
Laboratories Ltd. and Cipla,
Drug-makers across Asia are jostling to make generic
versions of Tamiflu once patent holder Roche relaxes
its grip on the anti-viral pill that could save many
lives in case of a bird flu pandemic.
.
From India to Southeast Asia, talks are underway with
the Swiss pharmaceutical giant for sub-licenses and
other arrangements to manufacture the highly sought-after
drug as governments beef up their stockpiles.
.
Roche, which had kept a tight rein on the manufacturing
process to ensure quality control, succumbed to global
pressure and agreed this month to share the technology
amid escalating warnings of a pandemic that could kill
millions.
.
Tamiflu is not a vaccine against avian flu, but eases
its impact and thus boosts patients' chances to survive
infection.
.
Evidence that bird flu has spread to Europe from Asia,
where the lethal H5N1 strain has killed more than 60
people since 2003, has increased demand for the drug
amid fears the virus will become easily transferable
among humans.
.
"Considering the recent spread of H5N1 virus, the Roche
decision was the responsible thing to do and should
be applauded," said Duane Gubler, director of the Hawaii-based
Asia-Pacific Institute for Tropical Medicine and Infectious
Diseases.
.
"If there is a pandemic, that decision could result
in helping to save many lives," he told AFP.
.
Koh Choon Hui, managing director of Roche Singapore
Pte Ltd, said the Basel-based group has been approached
by "around 100 companies including some governments"
in Asia for the production of Tamiflu.
.
"These requests are currently being assessed. It is
too early to comment who these governments and companies
are," Koh told AFP.
.
Roche is "willing to collaborate with companies which
have expertise in certain specialist manufacturing steps
such as fermentation and azide chemistry," he said.
.
It is also "willing to grant sub-licenses ... to companies
who can realistically produce substantial amounts of
Tamiflu for emergency pandemic use in accordance with
appropriate quality specifications, safety and regulatory
requirements."
.
Roche has said that the production of Tamiflu involves
a complex, 10-step process which takes about 12 months
and must be carried out in specialised factories.
.
Among the Asian firms interested in manufacturing the
medication are India's biggest generic drug-makers Ranbaxy
Laboratories Ltd. and Cipla, the first company to make
cheap AIDS drugs.
.
"We have initiated the process of dialogue with Roche
for a non-exclusive global voluntary license for the
manufacture and sale of the generic version of Tamiflu,"
Ranbaxy spokesman Ramesh L. Adige told AFP.
.
He said Ranbaxy could manufacture the active pharmaceutical
ingredients for Tamiflu "in a couple of months" after
meeting issues relating to intellectual property and
other regulatory clearances.
.
Cipla said earlier this month said it would follow its
strategy with the anti-AIDS drug by developing a low-cost
version of Tamiflu.
.
"We have no deal with Roche on the product, but could
explore a tie-up," Cipla joint managing director Amar
Lula told AFP in New Delhi.
.
In Taiwan, a health department official, Li Jih-heng.
said authorities are planning a trial production of
Tamiflu in December.
.
"We will continue efforts seeking a patent authorisation
from the Swiss company Roche to mass manufacture Tamiflu
but the trial production will go ahead to meet emergency
needs," Li told AFP in Taipei.
.
"The drug will be used to contain bird flu in the event
of an outbreak, not for commercial purposes."
.
Taiwanese legislators, citing threats of a possible
outbreak, have urged health authorities to immediately
mass-produce the drug even without Roche's authorisation.
.
Roche's Shanghai office has said it was also in touch
with the mainland Chinese government and had provided
it with full and updated information about the drug.
.
Roche is willing to allow other companies in China or
the government to produce the drug, it said.
.
Vietnam, which accounts for two-thirds of the H5N1 strain's
human fatalities, is in contact with Roche, according
to Cao Minh Quang, director of the Pharmaceuticals Administration
Department in Hanoi.
.
Quang said Vietnam could even decide to produce the
anti-viral drug without a licence in case of a pandemic
-- a situation in which governments would be under intense
pressure to put public health above respecting copyright
laws.
.
Koh, the managing director of Roche's Singapore office,
said he hoped the situation would not reach such a point.
.
"As Roche is willing to discuss and collaborate on technical
matters for the manufacturing of Tamiflu, there is no
need for these countries to violate patent laws," he
said.
.
Singapore said it was increasing its stockpiles of Tamiflu
but was not in talks with Roche to manufacture the drug.
.
Currently, Singapore has Tamiflu supplies to treat 430,000
people and expects more deliveries to enable it to treat
1.05 million people, or a quarter of the population,
within a year, the Ministry of Health (MOH) said.
.
"However, MOH will continue to watch the developments
in the area of generic anti-viral drugs and keep our
options open," it said. â AFP

Drug-makers across Asia are jostling to make generic
versions of Tamiflu once patent holder Roche relaxes
its grip on the anti-viral pill that could save many
lives in case of a bird flu pandemic.
.
From India to Southeast Asia, talks are underway with
the Swiss pharmaceutical giant for sub-licenses and
other arrangements to manufacture the highly sought-after
drug as governments beef up their stockpiles.
.
Roche, which had kept a tight rein on the manufacturing
process to ensure quality control, succumbed to global
pressure and agreed this month to share the technology
amid escalating warnings of a pandemic that could kill
millions.
.
Tamiflu is not a vaccine against avian flu, but eases
its impact and thus boosts patients' chances to survive
infection.
.
Evidence that bird flu has spread to Europe from Asia,
where the lethal H5N1 strain has killed more than 60
people since 2003, has increased demand for the drug
amid fears the virus will become easily transferable
among humans.
.
"Considering the recent spread of H5N1 virus, the Roche
decision was the responsible thing to do and should
be applauded," said Duane Gubler, director of the Hawaii-based
Asia-Pacific Institute for Tropical Medicine and Infectious
Diseases.
.
"If there is a pandemic, that decision could result
in helping to save many lives," he told AFP.
.
Koh Choon Hui, managing director of Roche Singapore
Pte Ltd, said the Basel-based group has been approached
by "around 100 companies including some governments"
in Asia for the production of Tamiflu.
.
"These requests are currently being assessed. It is
too early to comment who these governments and companies
are," Koh told AFP.
.
Roche is "willing to collaborate with companies which
have expertise in certain specialist manufacturing steps
such as fermentation and azide chemistry," he said.
.
It is also "willing to grant sub-licenses ... to companies
who can realistically produce substantial amounts of
Tamiflu for emergency pandemic use in accordance with
appropriate quality specifications, safety and regulatory
requirements."
.
Roche has said that the production of Tamiflu involves
a complex, 10-step process which takes about 12 months
and must be carried out in specialised factories.
.
Among the Asian firms interested in manufacturing the
medication are India's biggest generic drug-makers Ranbaxy
Laboratories Ltd. and Cipla, the first company to make
cheap AIDS drugs.
.
"We have initiated the process of dialogue with Roche
for a non-exclusive global voluntary license for the
manufacture and sale of the generic version of Tamiflu,"
Ranbaxy spokesman Ramesh L. Adige told AFP.
.
He said Ranbaxy could manufacture the active pharmaceutical
ingredients for Tamiflu "in a couple of months" after
meeting issues relating to intellectual property and
other regulatory clearances.
.
Cipla said earlier this month said it would follow its
strategy with the anti-AIDS drug by developing a low-cost
version of Tamiflu.

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